# K211449: Triton™ Sacroiliac Joint Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Choice Spine, LLC
- Decided: Aug 31, 2021 after 113 days
- Product code: OUR (Sacroiliac Joint Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K841189 (1984). 239 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 241 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203138: FIREBIRD SI Fusion System, Orthofix, Inc. (2020) Summary page 5.
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 5.
- K151818: SImmetry Sacroiliac Joint Fusion System, Zyga Technology, Inc. (2015) Summary page 5.
- K171686: Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System, Choicespine (2017) Summary page 5.

## Most influential descendants
- K211785: CASSATT™ SIJ Fixation System (2022), 0 descendants of its own

## Indications for use
The Triton™ Sacroiliac Joint Fixation system is intended for fixation of sacroiliac joint distruptions, and intended for sacroiliac joint fusion for conditions including; -sacroiliac joint disruptions, degenerative sacroilititis to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and -Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint

Source page: https://510kreport.com/device/K211449
Methodology: https://510kreport.com/methodology
